Primary percutaneous stenting of the bile ducts in patients with resectable perihilar cholangiocarcinoma - a pilot study

Conditions: Bile duct cancer
malignant hilar biliary obstruction
10004606

Registration Number: NL-OMON56845

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

• Written informed consent must be given according to ICH/GCP, and
national/local regulations.
• Resectable pCCA on imaging with histopathological confirmation or high
clinical suspicion (as determined by the multidisciplinary hepatobiliary team).
• Hyperbilirubinemia (a combination of a total bilirubin level >50 mmol/l.
• Age above 18 years

Exclusion Criteria

• Fluctuation or spontaneous decrease of a total bilirubin level before start
of any treatment suggesting potential benign origin.
• Patients who underwent previous drainage procedures endoscopically or
percutaneously with an internalized biliary catheter.
• Clinical signs of cholangitis. Cholangitis was defined as the presence of
both fever (i.e. body temperature >38.5°C) combined with leucocytosis (i.e. >=10
*109/L) without clinical or radiological evidence of acute cholecystitis
• Uncorrectable coagulation disorder.
• Uncorrectable contrast allergy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Major complications within 90 days after inclusion.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Severe drainage-related complications within 90 days after inclusion; absolute<br /><br>and relative (%) bilirubin decrease after 14 days (+/-4 days); proportion of<br /><br>patients with technical success of stent placement at initial drainage<br /><br>procedure; proportion of patients with successful drainage at initial drainage<br /><br>procedure; number of reinterventions and hospital admission days; proportion of<br /><br>patients who underwent surgical exploration and who underwent curative-intent<br /><br>surgical resection; proportion of uncomplicated stent removal from the future<br /><br>liver remnant during surgery; overall survival (OS); and cost-effectiveness.</p><br>